Vascular sheath with puncture site closure apparatus and methods of use

Abstract

Apparatus and methods are provided for use in sealing a vascular puncture site. The invention comprises an introducer sheath with an integrated closure component. The closure component includes an advanceable resilient spring clip with an expanded delivery configuration in which opposing sides do not contact one another, and an unstressed deployed configuration, in which opposing sides close towards one another. The clip is advanced along the sheath until it pierces opposing sides of a vessel wall at a puncture site. The sheath then is withdrawn, thereby causing the clip to resiliently return to its unstressed deployed configuration and draw opposing sides of the puncture together to seal the wound.

What is claimed is:  
     
       1. An apparatus for closing a puncture communicating between a patient's skin and a vessel, comprising: 
       an elongate member having proximal and distal regions and an exterior surface;  
       a housing slidably disposed on the exterior surface of the elongate member, the housing including a portion defining a chamber; and  
       a clip releasably disposed within the chamber, the clip being expandable from a deployed configuration wherein opposing sides of the clip are directed inwards towards one another, and a delivery configuration, in which the clip is accepted within the chamber.  
     
     
       2. The apparatus of  claim 1 , further comprising an actuator for deploying the clip from the chamber into engagement with tissue surrounding the puncture to close the puncture. 
     
     
       3. The apparatus of  claim 2 , wherein the actuator is configured for advancing the housing from the proximal region to the distal region of the elongate member. 
     
     
       4. The apparatus of  claim 2 , wherein the actuator is detachably coupled to the housing. 
     
     
       5. The apparatus of  claim 1 , further comprising a backbleed indicator port on the housing for indicating a position of the housing relative to the vessel. 
     
     
       6. The apparatus of  claim 1 , wherein the clip is biased to the deployed configuration and is resiliently expandable to the delivery configuration. 
     
     
       7. The apparatus of  claim 1 , wherein the clip is bioabsorbable. 
     
     
       8. A method for closing a puncture communicating between a patient's skin and a vessel, the method comprising: 
       advancing an elongate member through the puncture into the vessel;  
       advancing a housing distally along an exterior surface of the elongate member into the puncture, the housing having a clip therein;  
       engaging tissue adjacent the puncture with tissue-engaging elements on the clip; and  
       drawing the tissue-engaging elements towards one another to close the puncture.  
     
     
       9. The method of  claim 8 , wherein the step of drawing the tissue-engaging elements toward one another comprises withdrawing the elongate member from the puncture. 
     
     
       10. The method of  claim 9 , wherein the tissue-engaging elements are biased to resiliently move towards one another from a delivery configuration to a deployed configuration when the elongate member is withdrawn from the puncture. 
     
     
       11. The method of  claim 8 , wherein an actuator is used to advance the housing along the exterior surface of the elongate member into the puncture. 
     
     
       12. The method of  claim 11 , wherein the actuator is coupled to the housing before advancing the housing. 
     
     
       13. The method of  claim 12 , wherein the elongate member comprises a hub having a bore, and wherein a portion of the actuator is inserted into the bore of the hub before advancing the housing. 
     
     
       14. The method of  claim 8 , wherein the housing comprises an expander for expanding the clip, and wherein the step of engaging tissue comprises advancing the clip relative to the expander. 
     
     
       15. The method of  claim 8 , wherein the housing comprises a backbleed indicator port, and wherein the housing is advanced distally along the elongate member until blood from the vessel flows through the backbleed indicator port to a proximal region of the elongate member. 
     
     
       16. The method of  claim 8 , wherein the step of engaging tissue comprises engaging a wall of the vessel with the tissue-engaging elements. 
     
     
       17. The method of  claim 16 , wherein the step of engaging a wall of the vessel comprises piercing the wall of the vessel with the tissue-engaging elements. 
     
     
       18. A method for closing a puncture communicating between a patient's skin and a vessel, the method comprising: 
       advancing an elongate member through the puncture into the vessel;  
       advancing a closure component distally along an exterior surface of the elongate member into the puncture until blood from the vessel flows through a backbleed indicator port to provide visual confirmation that the closure component is disposed adjacent the vessel; and  
       withdrawing the elongate member from the puncture, leaving the closure component to seal the puncture.  
     
     
       19. The method of  claim 18 , wherein the closure component comprises a clip, and wherein the method further comprises engaging tissue adjacent the puncture with tissue-engaging elements on the clip. 
     
     
       20. An apparatus for closing a puncture communicating between a patient's skin and a vessel, comprising: 
       an elongate member having proximal and distal region and an exterior surface;  
       a housing slidably disposed on the exterior surface of the elongate member; and  
       a clip deployable from the housing comprising an annular device including a plurality of tissue-piercing element, the clip defining an expanded configuration within the housing and a deployed configuration once deployed from the housing in which opposing tissue-piercing elements are directed inwardly towards one another.  
     
     
       21. The apparatus of  claim 20 , further comprising an actuator for deploying the clip from the housing. 
     
     
       22. The apparatus of  claim 21 , wherein the actuator comprises a plunger extending from the proximal end of the elongate member. 
     
     
       23. The apparatus of  claim 20 , wherein the elongate member comprises a tubular member. 
     
     
       24. The apparatus of  claim 20 , wherein the clip is biased to the deployed configuration and is resiliently expandable to the expanded configuration. 
     
     
       25. The apparatus of  claim 20 , wherein the clip is bioabsorbable. 
     
     
       26. The apparatus of  claim 20 , wherein the tissue-piercing elements comprise at least one of spikes, hooks, and barbs. 
     
     
       27. A method for closing a puncture communicating between a patient's skin and a vessel, the method comprising: 
       advancing an elongate member through the puncture into the vessel;  
       advancing a clip distally along an exterior surface of the elongate member with tissue-piercing elements of the clip covered to prevent snagging;  
       piercing a wall of the vessel with the tissue-piercing elements; and  
       drawing the tissue-piercing elements inwardly towards one another to close the puncture.  
     
     
       28. The method of  claim 27 , wherein the step of drawing the tissue-piercing elements towards one another comprises withdrawing the elongate member from the puncture. 
     
     
       29. The method of  claim 28 , wherein the tissue-piercing elements are biased to resiliently move towards one another from a delivery configuration to a deployed configuration when the elongate member is withdrawn from the puncture.